Frettwork network GmbH

merken

International Regulatory Specialist (m/f/d)

Die Frettwork network GmbH ist eine agile und aufstrebende Personal- und Unternehmensberatung. Wir bieten neben der klassischen Personalsuche in unterschiedlichen internationalen Unternehmen und Branchen, weitreichendes Fachwissen in allen Human-Resources-Projekten an. Dazu zählen u.a. Bewerbercoaching, HR Interim Management, Outplacement und Employer Branding.

Aufgaben

Assess regulatory environments and requirements of existing and new jurisdictions and markets to ensure product quality documentation is maintained throughout the entire product life cycle

  • Generate accurate product quality documents, compliant with EMA regulations
  • Work closely and collaboratively with the Quality Team to ensure that all product quality documentation has the applicable data set for compliance
  • Understand and evaluate each market’s medical cannabis regulations to ensure that product quality documents for each market are compliant with regulations
  • Understand and evaluate each market’s medical cannabis regulations
  • Ensure that scientific data supporting submissions comply with applicable national and international regulations and guidelines
  • Provide GMP-related regulatory advice to other departments
  • Perform internal departmental regulatory compliance audits to facilitate sustained conformance
  • Review product labels or other required documentation to ensure compliance with International requirements

Anforderungen

B.Sc. degree in Biological/Life Sciences/Bioengineering or extensive experience and related training

  • Post-Graduate Regulatory Certification preferred
  • 3-5 years’ experience working within a pharmaceutical manufacturing, and/or warehousing with cGMP-compliant Quality Management System
  • Understanding of regulatory requirements for movement of controlled/uncontrolled drug products between different jurisdictions
  • Knowledge of EMA regulations related to product quality (GMP, GACP, GPP)
  • Understanding of product quality data generation, particularly for GMP compliance and Chemistry, Manufacturing and Controls
  • Proven ability to generate a variety of technical product quality documentation
  • Experience maintaining quality management systems and programs (ISO9001, GMP, HACCP) preferred
  • Proficiency in English and German; Portuguese and Spanish is an advantage
  • Willing to travel, approx. 20%



Einzelheiten zum Job Stellenart: Vollzeit
Anzahl Stellen: 1
Beginn: sofort
Dauer: unbefristet
Letzte Änderung: 17.04.2019

Arbeitsort Frettwork network GmbH
40210 Düsseldorf

Bewerbung Bitte bewerben Sie sich
per E-Mail

jobs@frettwork.de

Weitere Infos erhalten Sie unter:
www.frettwork.de